Surgical Access Combined With Systematically Administered Antibiotics in the Treatment of Peri-implantitis

Summary

This randomized clinical trial evaluates the clinical and microbiological (microbial complexes and changes in the diversity of the submucosal biofilm) effects of MTZ+AMX as adjuncts to anti-infectious surgical treatment plus Er: YAG in the treatment of peri-implantitis.

Conditions

• Peri-Implantitis

Interventions

PROCEDURE

Open flap debridement

After local anesthesia (2% lidocaine with1:100,000 epinephrine), intrasulcular incisions will be performed to create a horizontal flap extending beyond the adjacent teeth and/or implants. Buccal and lingual full-thickness flaps will be dissected, and granulation tissue will be removed to expose the implant threads and bone defect. The flap will be repositioned in its original position and stabilized with interrupted sutures, which will be removed after 10 days.

OTHER

Er: YAG irradiation

An Er:YAG laser (Lite Touch, Light Instruments, Israel) will be used, with an irradiation energy of 20 mJ, frequency of 20 Hz, output power of 0.4 W, and an energy density of 2.76 J/cm2. An 8 mm long sapphire tip will be used in the respective handpiece and not in contact with the titanium surface, with concomitant water spray irrigation, under air 6 and water spray 6, the irradiation angle will be 90 degrees, at a focal distance of 2 mm, with spot size diameter of 1.3 mm

DRUG

Metronidazole

Metronidazole 400 mg thrice a day for 14 days in the active phase of the periodontal treatment (beginning after open flap debridement).

DRUG

Amoxicillin

Amoxicillin 500 mg thrice a day for 14 days in the active phase of the periodontal treatment (beginning after open flap debridement).

DRUG

Placebos

Amoxicillin and metronidazole placebos thrice a day for 14 days in the healing phase (beginning after open flap debridement).

Sponsors & Collaborators

• ITI Foundation

  collaborator INDUSTRY

• University of Guarulhos

  lead OTHER

Principal Investigators

• Jamil A Shibli, Professor · University of Guarulhos

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-05-01

Primary Completion

2024-07-16

Completion

2024-07-16

Countries

• Brazil

Study Locations